DESIGN AND DEVELOPMENT OF MEDICAL ELECTRONIC ...

440 CARDIAC PACING AND DEFIBRILLATIONHowever, this document simply outlines the areas in which implantable pacemakersshould be tested (e.g., electrical characterization, interference, biocompatibility, animaltesting) so that they can be considered safe for human implant. This document does notprovide the specific performance requirements or testing methods available in the EN-45502 series of standards. This is not to say that the FDA doesn’t expect to see much, muchmore than what the guidance document sketches. Until a standard is adopted by FDA,however, it is up to the manufacturers to find ways of justifying the performance oftheir devices and to find ways of testing the devices for safety and effectiveness to satisfythe FDA.Nonimplantable pacemakers and defibrillators are also governed by particular standards:• IEC-601-2-31, Particular Requirements for the Safety of External Cardiac Pacemakerswith Internal Power Source, 1994, specifies the particular safety requirements forexternal pacemakers powered by an internal electrical power source. Applies also topatient cables but does not apply to equipment that can be connected directly or indirectlyto a power line.• IEC-601-2-4, Particular Requirements for the Safety of Cardiac Defibrillators andCardiac Defibrillator Monitors, 1983, specifies requirements for the safety of cardiacdefibrillators and cardiac defibrillator monitors incorporating a capacitive energystorage device.• ANSI/AAMI DF2, Cardiac Defibrillator Devices, 1989, provides minimum labeling,performance, and safety requirements for cardiac defibrillator devices. Requirementsfor performance cover energy range, limited energy output, energy accuracy, pulseshape and duration, controls and indicators, energy-level indicator, reduce-chargecapability, paddle electrode contact area, and other characteristics.• AAMI DF39, Automatic External and Remote Control Defibrillators, 1993, coverstesting and reporting performance results of automatic external defibrillators, primarilythrough description of the performance for the arrhythmia detection component.REFERENCESAAMI, AAMI/ANSI Standard HF18: Electrosurgical Devices, Annex B, 1994.Bocka, J. J., External Transcutaneous Pacemakers, Annals of Emergency Medicine, 18(12),1280–1286, 1989.Hoekstein, K. N., and G. F. Inbar, Cardiac Stroke Volume Estimation from Two Electrode ElectricalImpedance Measurements, EE Publication 911, Technion Institute of Technology, Haifa, Israel,1994.Irwin, D. D., S. Rush, R. Evering, E. Lepeschkin, D. B. Montgomery, and R. J. Weggel, Stimulationof Cardiac Muscle by a Time-Varying Magnetic Field, IEEE Transactions on Magnetics, 6(2),321–322, 1970.Prutchi, D., Rate Responsive Cardiac Pacemaker with Filtered Impedance Sensing and Method, U.S.patent 5,431,772, July 2, 1996.Prutchi, D., and M. Norris, Electro-optically Driven Solid State Relay System, U.S. patent6,335,538, January 1, 2002.